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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019271
Receipt No. R000022266
Scientific Title Efficacy of metallic stent for benign biliary stricture.
Date of disclosure of the study information 2015/10/07
Last modified on 2017/05/03

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Basic information
Public title Efficacy of metallic stent for benign biliary stricture.
Acronym Efficacy of metallic stent for benign biliary stricture.
Scientific Title Efficacy of metallic stent for benign biliary stricture.
Scientific Title:Acronym Efficacy of metallic stent for benign biliary stricture.
Region
Japan

Condition
Condition Benign biliary stricture
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the long-term efficacy and safty of matallic stent for benign biliary stricture requiring drainage.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes time of stent patency
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 biliary metallic stent
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients' age of more than 20 years-old.
2) Patients having biliary stricture requiring drainage caused by benign diseases as follow; chronic pancreatitis, autoimmune pancreatitis, inflammatory stricture, stricture of anastomosis after liver or bile duct resection including liver transplantation, biliary injury caused by surgical procedure, sclerosing cholangitis and lower biliary stricture caused by duodenal papillitis.
3) Patients having cholangitis, obstructive jaundice and liver dysfunction caused by benign biliary stricture.
4) Written informed consent is obtained from patient before the study.
Key exclusion criteria 1) Patients' age of less than 20 years-old.
2)Written informed consent is not obtained from patient before the study.
3) Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamitsu Sato
Organization Yokohama city university hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL +81-45-787-2640
Email tasatou-ykh@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamitsu Sato
Organization Yokohama city university hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL +81-45-787-2640
Homepage URL
Email tasatou-ykh@umin.ac.jp

Sponsor
Institute Yokohama city university hospital, Department of Gastroenterology and Hepatology.
Institute
Department

Funding Source
Organization Yokohama city university hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 07 Day
Last modified on
2017 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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